Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

Pfizer354 enrolled

Overview

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

354

Conditions

Hypercholesterolemia

Interventions

PBODRUG

Placebo Q28d

200mg PF-04950615 (RN316)DRUG

PF-04950615 200 mg, Q28d

300mg PF-04950615 (RN316)DRUG

PF-04950615 300 mg, Q28d

PBO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. * Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1: * Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L); * Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L). * Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial. Exclusion Criteria: * Participation in other studies within 3 months before the current study begins and/or during study participation. * Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product. * History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV. * Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%). * Poorly controlled hypertension.

Locations (74)

Outcomes

Primary Outcomes

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

Time frame: Baseline, Week 24

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Data from ClinicalTrials.gov

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PF-04950615DRUG

PF-04950615 50mg, Q14d

PF-04950615DRUG

PF-04950615 100 mg, Q14d

PF-04950615DRUG

PF-04950615 150mg, Q14d

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

The Office of James G. McMurray, MD

Huntsville, Alabama, United States

Southwest Heart Group

Tucson, Arizona, United States

Aureus Research Inc.

Little Rock, Arkansas, United States

Universal Biopharma Research Institute Inc. - Alta Family Health Clinic

Dinuba, California, United States

Clinical Trials Research

Lincoln, California, United States

The Office of Lucita M. Cruz, MD, Inc.

Norwalk, California, United States

Radiant Research

Santa Rosa, California, United States

St. Joseph's Medical Associates

Stockton, California, United States

...and 64 more locations

Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Total Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Total Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Triglycerides at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Triglycerides at Week 12 and 24

Time frame: Baseline, Week 12, 24

Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)

Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.

Time frame: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups

Percentage of Participants With Injection Site Adverse Events

Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.

Time frame: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups

Plasma Concentration of PF-04950615 at Week 12 and 24

Time frame: Week 12, 24

Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)

Time frame: Week 12, 24